Task Force Reports On Genetic Testing

Task Force Reports On Genetic Testing

Genetic Check: The analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites to detect heritable disease - related genotypes, mutations, phenotypes, or karyotypes for clinical purposes. Compatible purposes entail predicting risk of disease, identifying carriers, establishing prenatal and clinical diagnosis or prognosis, monitoring, and screening prenatally and in newborns, but they except tests conducted precisely for research.
The Task Force on Genetic Testing, chaired by Neil Holtzman ( Johns Hopkins University ), was formed in 1994 by the NIH - DOE Working Group on Ethical, Legal, and Social Implications of Human Genome Research. The working group asked the task force to review genetic testing in the United States and make recommendations to effect the development of safe and effective genetic tests to be delivered in high - quality laboratories and used appropriately by healthcare providers and consumers. The working group took this haste after considering the imperfect predictability of tests, quality of laboratories providing clinical genetic tests, scarcity of proven interventions for many disorders, and the ambiguous ability of many healthcare providers to define genetic tests accurately and nondirectively to patients.
In 1995, the task force undertook a survey of organizations likely to be engaged in genetic testing and conducted in - depth interviews at 29 of the 463 organizations. From respondents whose organizations performed genetic tests, the task force laid-back informational materials distributed to providers and patients. The task force then commissioned papers on some of the widely used genetic - screening programs in the United States. Individuals, both professionals and consumers, also were asked to report their experiences with various aspects of genetic testing.
Halfway through its deliberations, the task force published temporary education, held a public justice on them, and invited public comments. Taking these comments into consideration, the task force developed recommendations on which the public was and invited to comment. Final doctrine and recommendations were presented to the joint working group on May 9, 1997, and the final report was submitted in September ( http: / / www. hopkinsmedicine. org / tfgtelsi / ).
Summary of Recommendations
* The Secretary of Health and Human Services should appoint an advisory committee on genetic testing to be instrumental in implementing the task force ' s recommendations. The advisory committee or its term should entrench a system for importunate which genetic tests crave stringent scrutiny. * Protocols for developing genetic tests that can be used predictively must receive the tryout of an institutional review board if theory identifiers are retained and if the check is expected to be gladly available for clinical use. * To grant quick-witted decisions about inclination use, check developers must tender their validation and clinical data to independent review and to keen qualified organizations. * The task force urges the newly created genetics subcommittee of the Clinical Laboratory Improvement Advisory Committee to consider creating a genetics specialty to make certain that problems exclusive to genetic testing are addressed in assessments of laboratory quality. If only a subspecialty is practicable for DNA - and RNA - based tests, the subcommittee should then label how to confirm the quality of laboratories performing non - DNA and non - RNA predictive genetic tests. * The task force encourages the enlargement and strengthening of genetics curricula in medical school, box, and specialty training and the development and improvement of genetics programs by schools of nursing, public health, and social work. * Hospitals and managed - care organizations should hurting for evidence of function before permitting providers to order predictive genetic tests that depend upon stringent scrutiny or to counsel about them. * Physicians who encounter patients with symptoms and signs of singular genetic diseases should have access to accurate information that will enable them to add related diseases in their unalike diagnosis, to know where to turn for assistance in clinical and laboratory diagnosis, and to locate laboratories that test for rare diseases. The quality of laboratories providing tests for singular diseases must be ensured, and a comprehensive system must be admitted to collect data on unusual diseases.